510(k) · Cleared
ClearedManometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intersurgical, Inc. · CAP Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
Cleared on Jan 10, 2013 after a 178-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.
- Decided
- Jan 10, 2013
- Review
- 178 days
- Class
- Class II
- Product code
- CAP
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK122077 ManometerIntersurgical, Inc. · 2013
- Descendant · cites it directly · 1 of its ownK170663 Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP…Foremount Enterprise Co., Ltd. · 2018
- Descendant · 2 generations on · 0 of its ownK210288 Disposable Manual ResuscitatorXiamen Compower Medical Tech. Co., Ltd. · 2021
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K122077 | Manometer | Intersurgical, Inc. | 2013 | — |
| +1 | K170663 | Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve… | Foremount Enterprise Co., Ltd. | 2018 | — |
| +2 | K210288 | Disposable Manual Resuscitator | Xiamen Compower Medical Tech. Co., Ltd. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CAP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CAP device
- #1 K201666 Single Use Manometerscore 0.3 · 1 generation · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Ambu Disposable Pressure Manometer, REF 322004000 Named without a submission number |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170663 | Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount… | 2018 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K170663 (Foremount Enterprise Co., Ltd., 2018) has gone furthest, with 1 descendant of its own.
How does its category compare?
All CAP devicesCAP Monitor, Airway Pressure (Includes Gauge And/Or Alarm): FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · CAP
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · CAP
Too few CAP 510(k)s in any year since 2007 to give a median.
Recalls per year · CAP
No recall names CAP since 2007.
Adverse event reports per year · CAP
2in 2025
MAUDE reports naming product code CAP, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 3 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 4 |
| 2020 | 1 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 6 |
| 2023 | 0 | — | 0 | 11 |
| 2024 | 0 | — | 0 | 11 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Intersurgical In-line single patient use manometer is intended to be used
for monitoring the patients airway pressure during ventilation. The manometer
Is to be used with~ resuscitation systems and Mapleson C breathing circuits.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122077 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122077: Manometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122077
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026